Forsøg med terapeutisk kræftvaccine OSE2101 hos patienter med ikke-småcellet lungekræft og sekundær resistens over for immun checkpoint-hæmmer (ARTEMIA)
1. oktober 2026 opdateret af: OSE Immunotherapeutics
Et randomiseret, åbent, fase 3-forsøg, der sammenligner effektiviteten og sikkerheden af OSE2101 versus Docetaxel hos HLA-A2-positive patienter med metastatisk ikke-småcellet lungekræft (NSCLC) med sekundær resistens over for immun checkpoint-hæmmer
Multicenter, randomized (2:1), open-label phase 3 study in HLA-A2 positive patients with squamous and non-squamous metastatic NSCLC with ICI secondary resistance.
Patients will be randomized into 2 arms (randomization 2:1): experimental Arm A with OSE2101 monotherapy or control Arm B SoC with docetaxel monotherapy. Stratification factors will be histology (squamous versus non squamous) and ECOG Performance Status (0 versus 1).
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
363
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Caroline Chevalier, MSc, MPH
- Telefonnummer: +33 630 842 002
- E-mail: caroline.chevalier@ose-immuno.com
Undersøgelse Kontakt Backup
- Navn: Bérangère Vasseur, MD
- Telefonnummer: +33 676 448 160
- E-mail: berangere.vasseur@ose-immuno.com
Studiesteder
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Antwerpen
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Brasschaat, Antwerpen, Belgien, 2930
- Rekruttering
- Algemeen Ziekenhuis Klina
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Flemish Brabant
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Leuven, Flemish Brabant, Belgien, 3000
- Rekruttering
- Universitair Ziekenhuis Leuven - Campus Gasthuisberg
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Limburg
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Hasselt, Limburg, Belgien, 3500
- Rekruttering
- Jessa Ziekenhuis - Campus Virga Jesse
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Oost-Vlaaderen
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Ghent, Oost-Vlaaderen, Belgien, 9000
- Rekruttering
- Algemeen Ziekenhuis Maria Middelares
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Wallonia
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Namur, Wallonia, Belgien, B-5000
- Rekruttering
- Centre Hospitalier Universitaire Université Catholique de Louvain Namur - Site Sainte-Elisabeth
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West-Vlaanderen
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Kortrijk, West-Vlaanderen, Belgien, 8500
- Rekruttering
- Algemeen Ziekenhuis Groeninge - Campus Kennedylaan
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Roeselare, West-Vlaanderen, Belgien, 8800
- Rekruttering
- Algemeen Ziekenhuis Delta - Campus Rumbeke
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Roeselare, West-Vlaanderen, Belgien, 8800
- Aktiv, ikke rekrutterende
- Algemeen Ziekenhuis Delta - Campus Rembert Torhout
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Roeselare, West-Vlaanderen, Belgien
- Aktiv, ikke rekrutterende
- Algemeen Ziekenhuis Delta - Campus Menen
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Quebec
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Chicoutimi, Quebec, Canada, G7H 5H6
- Rekruttering
- Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay - Lac-Saint-Jean
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Montreal, Quebec, Canada, H4A 3J1
- Afsluttet
- McGill University Health Centre
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Rimouski, Quebec, Canada, G5L 5T1
- Rekruttering
- Centre Intégré de Santé et de Services Sociaux du Bas-Saint-Laurent
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England
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Leicester, England, Det Forenede Kongerige, LE2 9LX
- Rekruttering
- University Hospitals of Leicester NHS Trust
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Manchester, England, Det Forenede Kongerige, M20 4BX
- Rekruttering
- The Christie NHS Foundation Trust
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Metropolitan Borough of Wirral, England, Det Forenede Kongerige, CH63 4JY
- Rekruttering
- The Clatterbridge Cancer Centre NHS Foundation Trust
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Sutton, England, Det Forenede Kongerige, SM2 5PT
- Rekruttering
- The Royal Marsden NHS Foundation Trust
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Scotland
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Aberdeen, Scotland, Det Forenede Kongerige, AB25 2ZN
- Rekruttering
- NHS Grampian
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California
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Beverly Hills, California, Forenede Stater, 90211
- Rekruttering
- Clinical Research Advisors, LLC
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Encino, California, Forenede Stater, 90211
- Aktiv, ikke rekrutterende
- Clinical Research Advisors - Encino
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Los Angeles, California, Forenede Stater, 90048
- Aktiv, ikke rekrutterende
- Clinical Research Advisors - West Hollywood
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Los Angeles, California, Forenede Stater, 90211
- Aktiv, ikke rekrutterende
- Clinical Research Advisors - Korea Town
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Colorado
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Littleton, Colorado, Forenede Stater, 80218
- Trukket tilbage
- SCL Health - Saint Joseph Hospital Cancer Center
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Wheat Ridge, Colorado, Forenede Stater, 80033-6013
- Rekruttering
- Lutheran Medical Center - Cancer Centers of Colorado
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Connecticut
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Norwich, Connecticut, Forenede Stater, 06360
- Rekruttering
- Eastern Connecticut Hematology and Oncology Associates
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20007
- Rekruttering
- Georgetown Lombardi Comprehensive Cancer Center
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Florida
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Bradenton, Florida, Forenede Stater, 34210
- Aktiv, ikke rekrutterende
- Comprehensive Hematology Oncology - Bradenton Clinic
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Brandon, Florida, Forenede Stater, 33511
- Aktiv, ikke rekrutterende
- Comprehensive Hematology Oncology - Brandon Clinic
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Fleming Island, Florida, Forenede Stater, 32003
- Rekruttering
- Cancer Specialists of North Florida - Fleming Island
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Jacksonville, Florida, Forenede Stater, 32258
- Aktiv, ikke rekrutterende
- Cancer Specialists of North Florida - Baptist South
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Jacksonville, Florida, Forenede Stater, 32256-6932
- Rekruttering
- Cancer Specialists of North Florida - Southpoint
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Jacksonville, Florida, Forenede Stater, 32204
- Rekruttering
- Cancer Specialists of North Florida - Riverside
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Jacksonville, Florida, Forenede Stater, 32218
- Rekruttering
- Cancer Specialists of North Florida - Northside
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Jacksonville, Florida, Forenede Stater, 32207
- Rekruttering
- Cancer Specialists of North Florida Southside
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Jacksonville Beach, Florida, Forenede Stater, 32250
- Rekruttering
- Cancer Specialists of North Florida
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Largo, Florida, Forenede Stater, 33770
- Aktiv, ikke rekrutterende
- Comprehensive Hematology Oncology - Largo Clinic
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Neptune Beach, Florida, Forenede Stater, 32266
- Aktiv, ikke rekrutterende
- Cancer Specialists of North Florida - Beaches
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Palm Harbor, Florida, Forenede Stater, 34685
- Aktiv, ikke rekrutterende
- Comprehensive Hematology Oncology - Palm Harbor Clinic
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Saint Augustine, Florida, Forenede Stater, 32086
- Rekruttering
- Cancer Specialists Of North Florida - St. Augustine
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St. Petersburg, Florida, Forenede Stater, 33709
- Rekruttering
- Comprehensive Hematology Oncology
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St. Petersburg, Florida, Forenede Stater, 33709
- Aktiv, ikke rekrutterende
- Comprehensive Hematology Oncology - Bayfront Clinic
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Trinity, Florida, Forenede Stater, 34655
- Rekruttering
- Comprehensive Hematology Oncology - Trinity Clinic
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Rekruttering
- University of Illinois Cancer Center
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Kansas
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Merriam, Kansas, Forenede Stater, 66204
- Trukket tilbage
- Alliance for Multispecialty Research (AMR) - Kansas City Oncology
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70809
- Aktiv, ikke rekrutterende
- Mary Bird Perkins Cancer Center - Baton Rouge
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Covington, Louisiana, Forenede Stater, 70433
- Rekruttering
- Pontchartrain Cancer Center - Covington Office
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Hammond, Louisiana, Forenede Stater, 70403-1452
- Rekruttering
- Pontchartrain Cancer Center - Hammond Office
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Maryland
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Baltimore, Maryland, Forenede Stater, 21229
- Rekruttering
- Ascension Saint Agnes Hospital
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Massachusetts
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Worcester, Massachusetts, Forenede Stater, 01655
- Rekruttering
- University of Massachusetts Memorial Medical Center
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Nebraska
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Lincoln, Nebraska, Forenede Stater, 68506
- Rekruttering
- Nebraska Hematology-Oncology - Revive Research Institute LLC
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New York
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Babylon, New York, Forenede Stater, 11702
- Aktiv, ikke rekrutterende
- New York Cancer & Blood Specialists - Babylon Medical Oncology
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Brewster, New York, Forenede Stater, 10509
- Afsluttet
- Optum Medical Care - Carmel/Brewster Campus
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Brooklyn, New York, Forenede Stater, 11201
- Afsluttet
- Brooklyn Radiation Oncology
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Fishkill, New York, Forenede Stater, 12524
- Afsluttet
- Optum Medical Care - Fishkill Westage Campus
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Lake Success, New York, Forenede Stater, 11042
- Afsluttet
- Clinical Research Alliance
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Mount Kisco, New York, Forenede Stater, 10549
- Afsluttet
- Optum Medical Care - Mount Kisco Campus 90
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New Hyde Park, New York, Forenede Stater, 11042
- Afsluttet
- Optum Hematology Oncology - Lake Success
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New Hyde Park, New York, Forenede Stater, 11042
- Rekruttering
- New York Cancer & Blood Specialists - New Hyde Park
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New York, New York, Forenede Stater, 10028
- Rekruttering
- New York Cancer & Blood Specialists - Cancer Center - Research Headquarters
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New York, New York, Forenede Stater, 10028
- Aktiv, ikke rekrutterende
- New York Cancer & Blood Specialists - Central Park Medical Oncology
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Patchogue, New York, Forenede Stater, 11772
- Rekruttering
- New York Cancer & Blood Specialists - Patchogue Medical Oncology
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Port Jefferson Station, New York, Forenede Stater, 11776
- Aktiv, ikke rekrutterende
- New York Cancer & Blood Specialists - Port Jefferson Medical Oncology
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Port Jefferson Station, New York, Forenede Stater, 11776
- Aktiv, ikke rekrutterende
- New York Cancer & Blood Specialists - Port Jefferson Station Medical Oncology
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Poughkeepsie, New York, Forenede Stater, 12601
- Afsluttet
- Optum Medical Care - Poughkeepsie
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The Bronx, New York, Forenede Stater, 10469
- Aktiv, ikke rekrutterende
- New York Cancer & Blood Specialists - Eastchester Cancer Care Center
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The Bronx, New York, Forenede Stater, 10469
- Aktiv, ikke rekrutterende
- New York Cancer & Blood Specialists - Riverhead Medical Oncology
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Ohio
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Perrysburg, Ohio, Forenede Stater, 43551
- Aktiv, ikke rekrutterende
- Mercy Health - Perrysburg Cancer Center
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Toledo, Ohio, Forenede Stater, 43623
- Aktiv, ikke rekrutterende
- Mercy Health - St. Anne Cancer Center
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South Carolina
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Greenville, South Carolina, Forenede Stater, 29607
- Rekruttering
- Bon Secours Hematology and Oncology
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 36404
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Chattanooga - Medical Park II
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Chattanooga, Tennessee, Forenede Stater, 37404
- Rekruttering
- Tennessee Oncology - Chattanooga - Memorial Plaza
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Chattanooga, Tennessee, Forenede Stater, 37403
- Rekruttering
- Tennessee Oncology - Chattanooga - Downtown
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Chattanooga, Tennessee, Forenede Stater, 37403
- Rekruttering
- Tennessee Oncology - Chattanooga - GHCR Site I
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Cleveland, Tennessee, Forenede Stater, 37311
- Rekruttering
- Tennessee Oncology - Cleveland Clinic
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Cookeville, Tennessee, Forenede Stater, 38501
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Cookeville Clinic
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Dickson, Tennessee, Forenede Stater, 37055
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Dickson Clinic
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Franklin, Tennessee, Forenede Stater, 37067
- Rekruttering
- Tennessee Oncology - Franklin Clinic
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Gallatin, Tennessee, Forenede Stater, 37066
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Gallatin Clinic
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Hendersonville, Tennessee, Forenede Stater, 37075
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Hendersonville Clinic
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Hermitage, Tennessee, Forenede Stater, 37076
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Hermitage - Summit Clinic
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Lebanon, Tennessee, Forenede Stater, 37090
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Lebanon Clinic
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Murfreesboro, Tennessee, Forenede Stater, 37129
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Murfreesboro Clinic
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Nashville, Tennessee, Forenede Stater, 37203
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Nashville - Centennial Center for Blood Cancers Clinic
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Nashville, Tennessee, Forenede Stater, 37203
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Nashville - Centennial Clinic - Medical Oncology
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Nashville, Tennessee, Forenede Stater, 37203
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Nashville - Midtown Center for Blood Cancers
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Nashville, Tennessee, Forenede Stater, 37203
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Nashville - St. Thomas Midtown Clinic
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Nashville, Tennessee, Forenede Stater, 37207
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Nashville - Skyline Clinic
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Nashville, Tennessee, Forenede Stater, 37211
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Nashville - Southern Hills Clinic
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Nashville, Tennessee, Forenede Stater, 37232
- Rekruttering
- Greco-Hainsworth Tennessee Oncology Centers for Research (GHCR) - Corporate
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Nashville, Tennessee, Forenede Stater, 37205
- Rekruttering
- Tennessee Oncology - Nashville - St. Thomas West Clinic
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Shelbyville, Tennessee, Forenede Stater, 37160
- Rekruttering
- Tennessee Oncology - Shelbyville Clinic
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Smyrna, Tennessee, Forenede Stater, 37167
- Rekruttering
- Tennessee Oncology - Smyrna Clinic
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Washington
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Bonney Lake, Washington, Forenede Stater, 98391
- Aktiv, ikke rekrutterende
- Northwest Medical Specialties - Bonney Lake
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Federal Way, Washington, Forenede Stater, 98003
- Aktiv, ikke rekrutterende
- Northwest Medical Specialties - Federal Way
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Gig Harbor, Washington, Forenede Stater, 98332
- Rekruttering
- Northwest Medical Specialties - Gig Harbor
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Puyallup, Washington, Forenede Stater, 98373
- Rekruttering
- Northwest Medical Specialties - Puyallup Medical Oncology
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Tacoma, Washington, Forenede Stater, 98405
- Rekruttering
- Northwest Medical Specialties - Tacoma
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La Roche-sur-Yon, Frankrig, 85000
- Rekruttering
- Centre Hospitalier Départemental Vendée
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Le Mans, Frankrig, 72037
- Rekruttering
- Centre Hospitalier Le Mans
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Nantes, Frankrig, 44093
- Rekruttering
- Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec
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Alpes-de-Haute-Provence
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Toulon, Alpes-de-Haute-Provence, Frankrig, 83800
- Rekruttering
- Hôpital d'Instruction des Armées Sainte-Anne
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Alsace
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Strasbourg, Alsace, Frankrig, 67091
- Rekruttering
- Nouvel Hôpital Civil
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Auvergne-Rhône-Alpes
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Bron, Auvergne-Rhône-Alpes, Frankrig, 69500
- Aktiv, ikke rekrutterende
- Hôpital Louis Pradel
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Lyon, Auvergne-Rhône-Alpes, Frankrig, 69317
- Rekruttering
- Centre Hospitalier Lyon-Sud
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Lyon, Auvergne-Rhône-Alpes, Frankrig, 69317
- Rekruttering
- Hôpital de la Croix Rousse
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Bouches-du-Rhône
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Marseille, Bouches-du-Rhône, Frankrig, 13273
- Rekruttering
- Institut Paoli-Calmettes
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Doubs
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Besançon, Doubs, Frankrig, 25030
- Rekruttering
- Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz
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Finistère
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Brest, Finistère, Frankrig, 29200
- Rekruttering
- Centre Hospitalier Regional Universitaire Brest - Hopital de la Cavale Blanche
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Grand Est
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Mulhouse, Grand Est, Frankrig, 68100
- Rekruttering
- Hôpital Emile Muller
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Nancy, Grand Est, Frankrig, 54035
- Rekruttering
- Centre Hospitalier Régional Universitaire de Nancy
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Haute-Vienne
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Limoges, Haute-Vienne, Frankrig, 87000
- Rekruttering
- Centre Hospitalier Universitaire Dupuytren 1
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Hérault
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Montpellier, Hérault, Frankrig, 34295
- Rekruttering
- Hôpital Arnaud de Villeneuve
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Ille-et-Vilaine
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Rennes, Ille-et-Vilaine, Frankrig, 35033
- Rekruttering
- Hôpital Pontchaillou
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Loire-Atlantique
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Saint-Herblain, Loire-Atlantique, Frankrig, 44805
- Rekruttering
- Institut de Cancérologie de l'Ouest - Saint-Herblain - Site René Gauducheau
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Maine-et-Loire
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Cholet, Maine-et-Loire, Frankrig, 49325
- Rekruttering
- Centre Hospitalier (Ch) De Cholet
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Midi-pyrenees
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Toulouse, Midi-pyrenees, Frankrig, 31059
- Rekruttering
- Hôpital Larrey
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New Aquitaine
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Pessac, New Aquitaine, Frankrig, 33604
- Rekruttering
- Hôpital Haut-Lévêque
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Provence-Alpes-Côte d'Azur Region
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Marseille, Provence-Alpes-Côte d'Azur Region, Frankrig, 13015
- Rekruttering
- Hôpital Nord de Marseille
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Pyrénées-Atlantiques
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Bayonne, Pyrénées-Atlantiques, Frankrig, 64109
- Rekruttering
- Centre Hospitalier de la Côte Basque
-
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Rhône
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La Tronche, Rhône, Frankrig, 38700
- Rekruttering
- Hôpital Michallon
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Val-de-Marne
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Villejuif, Val-de-Marne, Frankrig, 94805
- Rekruttering
- Gustave Roussy
-
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Vaucluse
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Avignon, Vaucluse, Frankrig, 84000
- Rekruttering
- Institut Sainte Catherine
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Vienne
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Poitiers, Vienne, Frankrig, 86021
- Rekruttering
- Centre Hospitalier Universitaire de Poitiers
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Île-de-France Region
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Bobigny, Île-de-France Region, Frankrig, 93000
- Rekruttering
- Hôpital Avicenne
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Créteil, Île-de-France Region, Frankrig, 94000
- Rekruttering
- Centre Hospitalier Intercommunal de Créteil
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Paris, Île-de-France Region, Frankrig, 75014
- Rekruttering
- Hôpital Cochin
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Paris, Île-de-France Region, Frankrig, 75014
- Rekruttering
- Groupe Hospitalier Paris Saint-Joseph
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Paris, Île-de-France Region, Frankrig, 75020
- Rekruttering
- Hôpital Tenon
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Athens
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Piraeus, Athens, Grækenland, 185 47
- Rekruttering
- Metropolitan Hospital
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Attica
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Athens, Attica, Grækenland, 11527
- Rekruttering
- General Hospital for Thoracic Diseases Sotiria
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Athens, Attica, Grækenland, 11522
- Rekruttering
- Saint Savvas Anticancer - Oncological Hospital of Athens
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Athens, Attica, Grækenland, 11526
- Rekruttering
- Henry Dunant Hospital Center
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Nea Kifissia, Attica, Grækenland, 14564
- Rekruttering
- Agii Anargiri Cancer Hospital
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Central Macedonia
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Thessaloniki, Central Macedonia, Grækenland, 55236
- Rekruttering
- Clinic Agios Loukas
-
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Crete
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Heraklion, Crete, Grækenland, 711 10
- Rekruttering
- University General Hospital of Heraklion (PAGNI)
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Macedoni
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Thessaloniki, Macedoni, Grækenland, TK 56403
- Aktiv, ikke rekrutterende
- General Hospital of Thessaloniki Papageorgiou
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Peloponnese
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Patra, Peloponnese, Grækenland, 26504
- Rekruttering
- University General Hospital of Patras
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Thessaloniki
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Thessaloniki, Thessaloniki, Grækenland, 546 39
- Rekruttering
- Theagenio Anti-Cancer Hospital of Thessaloniki
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Thessaly
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Larissa, Thessaly, Grækenland, 411 10
- Rekruttering
- University General Hospital of Larissa
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-
-
-
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Groningen, Holland, 9713 GZ
- Rekruttering
- Universitair Medisch Centrum Groningen
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Gelderland
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Nijmegen, Gelderland, Holland, 6525 GA
- Rekruttering
- Radboud Universitair Medisch Centrum
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South Holland
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Rotterdam, South Holland, Holland, 3015 GD
- Rekruttering
- Erasmus Medisch Centrum
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-
-
-
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Genova, Italien, 16132
- Rekruttering
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Policlinico San Martino
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Lecce, Italien, 73100
- Rekruttering
- Ospedale Vito Fazzi Lecce
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Milan, Italien, 20132
- Rekruttering
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
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Milan, Italien, 20133
- Rekruttering
- Fondazione IRCCS - Istituto Nazionale dei Tumori
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Novara, Italien, 28100
- Rekruttering
- Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
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Padova, Italien, 35128
- Rekruttering
- Ospedale Busonera - Istituto Oncologico Veneto (IOV) - Padua
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Pisa, Italien, 56126
- Rekruttering
- Azienda Ospedaliero-Universitaria Pisana
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Rimini, Italien, 47923
- Aktiv, ikke rekrutterende
- Azienda Unità Sanitaria Locale della Romagna - Ospedale Infermi di Rimini
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Roma, Italien, 00144
- Rekruttering
- IRCCS Istituto Nazionale Tumori Regina Elena
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Rome, Italien, 00152
- Rekruttering
- Azienda Ospedaliera San Camillo Forlanini
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Siena, Italien, 53100
- Rekruttering
- Azienda Ospedaliera Universitaria Senese - L'ospedale Santa Maria alle Scotte
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Forlì-Cesena
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Meldola, Forlì-Cesena, Italien, 47014
- Rekruttering
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
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Lucca
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San Filippo, Lucca, Italien, 55100
- Rekruttering
- Presidio Ospedaliero di Lucca
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Milan
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Rozzano, Milan, Italien, 20089
- Aktiv, ikke rekrutterende
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas
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Naples
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Naples, Naples, Italien, 80131
- Rekruttering
- Azienda Ospedaliera Universitaria - Università degli Studi della Campania Luigi Vanvitelli
-
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Torino
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Orbassano, Torino, Italien, 10043
- Rekruttering
- Azienda Ospedaliero - Universitaria San Luigi Gonzaga
-
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Verona
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Legnago, Verona, Italien, 37045
- Rekruttering
- Ospedale P. Pederzoli - Casa di Cura Privata S.p.A.
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Greater Poland Voivodeship
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Konin, Greater Poland Voivodeship, Polen, 62-500
- Rekruttering
- Przychodnia Lekarska KOMED Roman Karaszewski
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Poznan, Greater Poland Voivodeship, Polen, 60-569
- Rekruttering
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów
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Kuyavian-Pomeranian Voivodeship
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Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polen, 85-796
- Rekruttering
- Centrum Onkologii Im. Prof. F. Łukaszczyka w Bydgoszczy
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Polen, 20-090
- Rekruttering
- Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
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-
Lódzkie
-
Lodz, Lódzkie, Polen, 93-338
- Rekruttering
- Instytut Centrum Zdrowia Matki Polki
-
-
Pomeranian Voivodeship
-
Gdansk, Pomeranian Voivodeship, Polen, 80-210
- Rekruttering
- Uniwersyteckie Centrum Kliniczne w Gdańsku
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-
-
-
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Coimbra, Portugal, 3000-075
- Rekruttering
- Unidade Local de Saúde de Coimbra
-
Lisbon, Portugal, 1769-001
- Rekruttering
- Unidade Local de Saúde de Santa Maria, E. P. E. - Hospital Pulido Valente
-
Lisbon, Portugal, 1769-001
- Rekruttering
- Hospital CUF Descobertas
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Porto, Portugal, 14341
- Rekruttering
- Hospital CUF Porto
-
Vila Nova de Gaia, Portugal, 4434-502
- Rekruttering
- Unidade Local de Saúde de Gaia/Espinho, E. P. E
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-
-
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Cluj
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Cluj-Napoca, Cluj, Rumænien, 400015
- Rekruttering
- Institutul Oncologic Prof. Dr. Ion Chiricuta
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Dolj
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Craiova, Dolj, Rumænien, 200746
- Rekruttering
- Centrul de Oncologie Sf Nectarie
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Timiș County
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Timișoara, Timiș County, Rumænien, 300239
- Rekruttering
- SC OncoMed SRL
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-
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Barcelona, Spanien, 08036
- Rekruttering
- Hospital Clinic de Barcelona
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Barcelona, Spanien, 08028
- Rekruttering
- Hospital Universitari Dexeus
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Barcelona, Spanien, 08017
- Rekruttering
- Clínica Mi Tres Torres
-
Barcelona, Spanien, 08035
- Rekruttering
- Hospital Universitari Vall d'Hebrón
-
Córdoba, Spanien, 14004
- Rekruttering
- Hospital Universitario Reina Sofía
-
Girona, Spanien, 17007
- Rekruttering
- Hospital Universitari de Girona Dr. Josep Trueta
-
Lugo, Spanien, 27004
- Rekruttering
- Hospital Universitario Lucus Augusti
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Madrid, Spanien, 28046
- Rekruttering
- Hospital Universitario La Paz
-
Madrid, Spanien, 28007
- Rekruttering
- Hospital General Universitario Gregorio Marañón
-
Madrid, Spanien, 28034
- Rekruttering
- Hospital Universitario Ramón y Cajal
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Málaga, Spanien, 29011
- Rekruttering
- Hospital Regional Universitario de Málaga - Hospital General
-
Seville, Spanien, 41009
- Rekruttering
- Hospital Universitario Virgen Macarena
-
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Balearic Islands
-
Palma de Mallorca, Balearic Islands, Spanien, 07198
- Rekruttering
- Hospital Son Llàtzer
-
-
Barcelona
-
Badalona, Barcelona, Spanien, 08916
- Rekruttering
- Hospital Germans Trias i Pujol
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L'Hospitalet de Llobregat, Barcelona, Spanien, 08907
- Rekruttering
- Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
-
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Biscay
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Barakaldo, Biscay, Spanien, 48903
- Rekruttering
- Biocruces Bizkaia Instituto de Investigación Sanitaria
-
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La Coruña
-
A Coruña, La Coruña, Spanien, 15006
- Rekruttering
- Complejo Hospitalario Universitario A Coruña
-
-
Las Palmas
-
Las Palmas de Gran Canaria, Las Palmas, Spanien, 35016
- Rekruttering
- Complejo Hospitalario Universitario Insular Materno Infantil
-
-
Madrid
-
Majadahonda, Madrid, Spanien, 28222
- Rekruttering
- Hospital Universitario Puerta de Hierro - Majadahonda
-
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Malaga
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Marbella, Malaga, Spanien, 29660
- Rekruttering
- HC Marbella
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-
-
-
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Berlin, Tyskland, 13353
- Rekruttering
- Charité - Universitätsmedizin Berlin
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Baden-Wurttemberg
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Heidelberg, Baden-Wurttemberg, Tyskland, 69126
- Rekruttering
- Thoraxklinik-Heidelberg
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Stuttgart, Baden-Wurttemberg, Tyskland, 70376
- Rekruttering
- Robert-Bosch-Krankenhaus
-
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Bavaria
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Gauting, Bavaria, Tyskland, 82131
- Rekruttering
- Asklepios Fachkliniken München-Gauting
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München, Bavaria, Tyskland, 81925
- Rekruttering
- München Klinik Bogenhausen
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Hesse
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Kassel, Hesse, Tyskland, 34125
- Aktiv, ikke rekrutterende
- Klinikum Kassel
-
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North Rhine-Westphalia
-
Aachen, North Rhine-Westphalia, Tyskland, 52074
- Afsluttet
- Universitätsklinikum Aachen
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Bonn, North Rhine-Westphalia, Tyskland, 53127
- Rekruttering
- Universitätsklinikum Bonn
-
Essen, North Rhine-Westphalia, Tyskland, 45147
- Rekruttering
- Universitätsklinikum Essen
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Saarland
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Homburg, Saarland, Tyskland, 66421
- Rekruttering
- Universitätsklinikum Gießen und Marburg - Gießen
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Saxony-Anhalt
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Halle, Saxony-Anhalt, Tyskland, 06120
- Rekruttering
- Krankenhaus Martha-Maria Halle-Dölau
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Schleswig-Holstein
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Großhansdorf, Schleswig-Holstein, Tyskland, 22927
- Rekruttering
- LungenClinic Grosshansdorf
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-
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Budapest, Ungarn, 1121
- Rekruttering
- Országos Korányi Pulmonológiai Intézet
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Gyöngyös, Ungarn, 3200
- Rekruttering
- Clinexpert Kft. telephelye, Bugát Pál Kórház - Phase I. Clinical Trial Site
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Heves County
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Gyöngyös, Heves County, Ungarn, 3200
- Afsluttet
- Mátrai Gyógyintézet
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Male or female, aged ≥ 18 years
- Patients expressing HLA-A2 phenotype in blood by pre-screening central laboratory
- Patients with histologically or cytologically squamous or non-squamous documented NSCLC, metastatic stage at study entry, not eligible for definite surgery or radiation, without EGFR, ALK and ROS1 gene alterations eligible for targeted therapy; for patients with squamous NSCLC, the molecular tests are not mandatory if age ≥ 50 years old and smoker ≥ 15 pack years; other sensitizing mutations known to be immunosensitive are eligible in case of lack of local access to targeted therapy (i.e.; KRAS G12C and BRAF mutations) after Sponsor' agreement.
- Patients with secondary resistance to ICI;
Other inclusion and exclusion criteria will apply per protocol.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Arm A: OSE2101
Unit dose: 1 mL corresponding to a total of 5 mg of the combination of peptides Mode/Route: Subcutaneous injection Regimen: One injection every three weeks for six cycles, then every eight weeks for the remainder of year one and, finally every twelve weeks until the end of second year. |
OSE2101 is a peptidic cancer vaccine composed of nine epitopes restricted to HLA-A2 phenotype targeting the tumor associated antigens of P53, HER-2, CEA, MAGE-2 and MAGE-3, and one pan-HLA DR binding epitope (PADRE), all epitopes emulsified in Montanide ISA 51TM adjuvant. Amp-HLA-A-CDx Tedopi for amplification of human genomic DNA (gDNA), LFK-CDx Tedopi kit (library full kit) for library preparation, NGSengine-CDx Tedopi software for analysis of NGS data files. |
|
Aktiv komparator: Arm B: Docetaxel
Unit dose: 75 mg/m2 Mode/Route: Intravenous infusion over 1 hour Regimen: One infusion every three weeks. |
Amp-HLA-A-CDx Tedopi for amplification of human genomic DNA (gDNA), LFK-CDx Tedopi kit (library full kit) for library preparation, NGSengine-CDx Tedopi software for analysis of NGS data files. Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions. |
|
Andet: GenDx CDx Tedopi
System of qualitative companion diagnostic devices, consisting of a polymerase chain reaction (PCR) assay Amp-HLA-A-CDx Tedopi, a DNA library preparation assay, LFK-CDx Tedopi and the software NGSengine-CDx Tedopi. |
Amp-HLA-A-CDx Tedopi for amplification of human genomic DNA (gDNA), LFK-CDx Tedopi kit (library full kit) for library preparation, NGSengine-CDx Tedopi software for analysis of NGS data files. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
OS defined as time from randomization to death
Tidsramme: From randomization date through study completion, an average of 3 years
|
OS defined as time from randomization to death of any cause, censored until the data analysis cut-off date |
From randomization date through study completion, an average of 3 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
3. december 2024
Primær færdiggørelse (Anslået)
15. december 2027
Studieafslutning (Anslået)
15. december 2028
Datoer for studieregistrering
Først indsendt
7. juni 2024
Først indsendt, der opfyldte QC-kriterier
21. juni 2024
Først opslået (Faktiske)
25. juni 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. oktober 2026
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Luftvejssygdomme
- Lungesygdomme
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Lungeneoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Karcinom, ikke-småcellet lunge
- Organiske kemikalier
- Kulbrinter
- Cycloparaffiner
- Kulbrinter, alicyklisk
- Kulbrinter, cyklisk
- Terpenes
- Taxoider
- Cyclodecanes
- Diterpenes
- Docetaxel
Andre undersøgelses-id-numre
- OSE2101C302
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ja
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .